BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 2103469 · Received May 26, 2011

    Report

    Report Number
    2024168-2011-03713
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 10, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED WITHOUT RELATED COMPONENTS. EVALUATION OF THE RETURNED DEVICE REVEALED NO TISSUE ATTACHED TO THE DEVICE AS REPORTED. A POSSIBLE CAUSE FOR THE REPORTED PRODUCT EXPERIENCE INCLUDE, BUT NOT LIMITED TO, TISSUE BEING CAPTURED BENEATH THE FOOT DURING ITS DEPLOYMENT. SUBSEQUENTLY, WHEN THE FOOT WAS CLOSED, TISSUE COULD HAVE BEEN CAUGHT WITHIN THE FOOT AND REMOVED WITH THE DEVICE. HOWEVER, DURING TESTING, THE FOOT WAS DEPLOYED AND THERE WAS NO TISSUE OBSERVED WITHIN OR UNDER THE FOOT. BASED ON THE INVESTIGATION FINDINGS, THE REPORTED PRODUCT EXPERIENCE COULD NOT BE CONFIRMED AND NO DEFINITIVE CAUSE COULD BE IDENTIFIED. NO MANUFACTURING OR QUALITY DEFICIENCY WAS DETECTED AS THE DEVICE WAS REPORTED TO BE FULLY FUNCTIONAL AS INTENDED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT DATABASE FOR THIS LOT REVEALED NO OTHER INCIDENTS WITH REPORTED, A PIECE OF INTIMA WAS REMOVED WITH THE DEVICE. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATIONS THEY ARE SUBJECT TO INSPECTION DURING MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, A PIECE OF INTIMA WAS REMOVED WITH THE PROGLIDE. NO TREATMENT WAS PERFORMED. HEMOSTASIS WAS ACHIEVED WITH THE PROGLIDE DEVICE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 030356H

    Patients

    Seq Age Sex Outcome Treatment
    1 Other